This position is grant funded

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

HYC Clinical Research Coordinator

 

Occupational Summary:  Within the operational research program of the Hubert -Yeargan Center for Global Health (HYC), the Clinical Research Coordinator (CRC) will provide high-level clinical research support and management to faculty investigators global research projects that include active participation with the planning, conduct, close-out of prospective research studies involving both US and overseas partner sites; perform a variety of complex duties involved in clinical research operations and clinical data management.  This position will sit within HYC Research Program Office (RPO) and report to HYC Managing Director.

 

General Duties and Leadership 15%

Support day-to-day operations of clinical research studies conducted by HYC faculty investigators and collaborating stakeholders and partner sites. Supervise junior level CRCs and research associates Collaborate and communicate across units working effectively with study investigators, CRU ARPMs, program managers, project leaders. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Actively facilitates and leads multiple study team's adoption of change in their working environment. Develops and implements solutions that work within the existing leadership or organizational structure. Perform a variety of complex duties involved in the collection, compilation, documentation, data provenance, and analysis of clinical research data. Support development and implementation of comprehensive and efficient clinical quality management plan (CQMP) for robust clinical and laboratory data collection. Participate and contribute in team meetings, coordinate activities with team members particularly related to regulatory, study enrollment, sample/data collection, and quality data management. Contribute to site assessment, field training, and quality reviews/site monitoring, and study reports; participate in protocol/consent development, IRB submissions, and CRF/REDCap development. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.

 

Regulatory/Ethics 20%

Knowledgeable in regulatory and institutional policies and processes, applies appropriately in study documentation, protocol submissions, and SOPs. Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Coordinate closely with global partner site personnel in the local and regional Ethics study review and approval process while maintaining cultural- or regional-specific requirements and considerations, track regulatory progress and annual renewals, and provide updates to the Duke IRB as needed. Coordinate closely with the regulatory coordinator and project manager to track and maintain IRB compliance including annual continuing renewals/approvals, protocol amendments, and contributing to enrollment and safety reports. Assure team members and study personnel human subjects trainings and certifications are current and maintained for IRB compliance. Work with relevant CRU and DOCR personnel to assure institutional compliance including submitting and maintaining the study protocol in clinicaltrials.gov, and development of a CQMP and RSDP.

Clinical Operations 45%

Work closely with the study PI, collaborating investigators, and team members in the start-up, conduct, management and close-out of clinical research studies and prospective trials. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. Collaborate with team members and site investigators research teams in the development of CRFs/EDCs and build of clinical databases (eg, REDCap) working to address cultural and regional-specific requirements, participate in user testing and training of study personnel and site field staff in the collection of clinical and laboratory data. Support the development of CQMP/monitoring plans to assure regulatory compliance and data/sample quality assurance, support implementation of the monitoring plan that may involve site visits for study monitoring and site staff training or retraining; participate in study data verification and reconciliation process, assist in database lock and close-out procedures. Conducts study monitoring including remote or in-person visits of partner sites in accordance with the study monitoring plan; assess data quality, protocol compliance, and study progress, and report any findings and corrective actions as appropriate to the study PI, site investigators and regulatory authorities as needed. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. Support development and implementation of operational standards including process flows, training manual (MOP), and SOPs for quality standards across international sites and program cores. Performs de-identification on data sets (does not include redacting participant records) to Safe Harbor standards as permitted by the protocol and contracts (e.g., DTA, DUA, and CTA). Predicts areas of vulnerability in the data flow plan.  Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Innovatively uses technology to enhance a research process. Prepares studies for closeout and document storage. May train or oversee others.

 

Coordination of Global Sites 20%

Develop and implement a tracking system for capturing, maintaining, and reporting of enrollment statistics per site and across partner sites. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. Provide training for quality sample collection at partner sites, and assist in specimen management and shipping from global sites and partner institutions. Manage the coordination of data collection and REDCap entry at each global site, and data transfer process across partner sites and institutions. Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol, coordinate with partner sites and Duke or local vendors to assure needed study supplies and management of supply inventories across sites.

 

Minimum Qualifications Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Preferred Education/Training Required

Work requires analytical, communication and organizational skills acquired through completion of a bachelor’s degree plus 4-6 years relevant experience or Master’s degree with 2-4 years relevant experience.

 

Candidates demonstrating interest and/or experience in global health or international research is highly desired.

 

Preference for CCRP certification

Prefer candidate with understanding of the complexities of communicating and operating with international partners. Experience in managing multiple research teams, particularly international teams is highly desired.  Looking for a minimum four years in clinical research, research administration, or clinical trial capacity in academia or industry, and preference to skills and knowledge in support of overseas projects

 

Technical Skills required

Regulatory/IRB process, study monitoring, data provenance and verification

 

Technical Skills preferred

Duke IRB/IRIS, MS Office, SOPs, REDCap other EDCs

 

“Soft Skills” required

Professional demeanor; excellent oral and written communication skills; attention to detail; flexible, able to multitask and adapt to changing priorities; self-starter; high energy; team player; personable

 

The above statements describe the general nature and level of work being performed and are not intended to be an exhaustive list of all responsibilities and duties required.

 

 

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.